Matrix-Delivered Autologous Mesenchymal Stem Cell Therapy for Refractory Rectovaginal Crohn’s Fistulas.
Inflamm Bowel Dis. 2019 Oct 12. pii: izz215. doi: 10.1093/ibd/izz215. [Epub ahead of print]
Lightner AL1, Dozois EJ2, Dietz AB3, Fletcher JG4, Friton J5, Butler G3, Faubion WA5.
- Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio, USA.
- Division of Colon and Rectal Surgery, Rochester, Minnesota, USA.
- IMPACT Lab, Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Rochester, Minnesota, USA.
- Department of Radiology, Rochester, Minnesota, USA.
- Department of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA.
Crohn’s rectovaginal fistulizing disease remains notoriously difficult to treat. A phase I clinical trial to evaluate the safety and feasibility of a novel protocol using a mesenchymal stem cell (MSC)-coated Gore Bio-A fistula plug for the treatment of medically and surgically refractory Crohn’s rectovaginal fistulas was conducted.
Five patients underwent an autologous subcutaneous adipose tissue harvest via a 2-cm abdominal wall incision at time of exam under anesthesia (EUA) with seton placement. MSCs were isolated, expanded, and impregnated on the plug. After 6 weeks, patients returned to the operating room for placement of the MSC-coated plug. The primary end points were safety and feasibility; the secondary end point was clinical and radiographic healing at 6 months.
Five female patients (median age [range], 49 [38-53] years) with a median disease duration (range) of 23 (7-34) years who were on biologic (n = 5) or combination therapy (n = 3) had successful harvest and expansion of MSCs and delivery of the Gore Bio-A plug. There were no serious adverse events or adverse events related to the MSCs or plug during the 6-month follow-up. At 6 months, 3 patients had complete cessation of drainage, and 2 had >50% reduction in drainage; all had a persistent fistula tract identified on magnetic resonance imaging and EUA at 6 months.
Surgical placement of an autologous adipose-derived MSC-coated fistula plug in diverted patients with Crohn’s rectovaginal fistulas was safe and feasible. All patients had a reduction in the size of their fistula tract, and 3 of 5 had cessation of drainage, but none achieved complete healing.This was a phase I clinical trial of autologous mesenchymal stem cells on a plug for rectovaginal Crohn’s fistulas.
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